Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medstar Health Research Institute
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Individual is ≥ 18 and ≤ 85 years of age.
2. Individual has a systolic blood pressure (SBP) ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
3. Individual is adhering to a stable (maximally tolerated dose) drug regimen including 3 or more anti-hypertensive medications for at least 1 month (including one diuretic) that is expected to be maintained for at least 6 months.
4. Individual is competent and willing to provide informed consent to participate in the trial.
1\. Individual has main renal arteries measuring \<2.75 mm in diameter.
You may not be if
1. Inability to sign written informed consent.
2. Individual has renal artery anatomy that is ineligible for treatment including:
1. Main renal arteries with \<20 mm treatable length
2. Renal artery stenosis of ≥20% by angiography.
3. A history of prior renal artery intervention including balloon angioplasty or stenting.
4. Multiple main renal arteries in either kidney.
3. Individual has an eGFR of \< 45mL/min/1.73m2, using the MDRD formula calculation.
4. Individual has had \>1 hospital admission for a hypertensive crisis within the past year.
5. Individual has an Ambulatory Blood Pressure Monitoring 24 hour average SBP\<135mmHg.
6. Individual has has \> 1 episode(s) of orthostatic hypotension (reduction of SBP of \>20 mmHg or diastolic blood pressure (DBP) of \>10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
7. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
8. Individual has primary pulmonary hypertension.
9. Individual has scheduled or planned surgery or cardiovascular intervention in the next 3 months.
10. Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
11. Individual is pregnant, nursing or planning to be pregnant.
12. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
13. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
14. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
15. Individual is currently enrolled in another investigational drug or device trial.
Clareo Health | Renal Denervation in Patients With Uncontrolled Blood Pressure
